A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)

NCT05343455 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DFD-29-CD-005
• Study Type: interventional
• Target: 330
• Locations: 2 countries
• Sites: 24

Brief Summary

This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (2)

• Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.

  Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.

  Baseline to Week 16

• Change in Total Inflammatory Lesion Count Compared to Placebo.

  Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.

  Baseline to Week 16.

Secondary Outcomes (3)

• IGA Treatment Success Compared to Doxycycline.

  Baseline to Week 16.

• Change in Total Inflammatory Lesion Count Compared to Doxycycline.

  Baseline to Week 16.

• Clinician's Erythema Assessment (CEA) Change Compared to Placebo.

  Baseline to Week 16.

Study Arms (3)

DFD-29

EXPERIMENTAL

DFD-29 (40 mg) extended release capsules

Drug: DFD-29

Doxycycline 40 mg

ACTIVE COMPARATOR

Doxycycline 40 mg modified release capsules

Drug: Doxycycline

Placebo

PLACEBO COMPARATOR

Placebo capsules matching DFD-29

Drug: Placebo

Interventions

DFD-29 DRUG

DFD-29 (40 mg) extended release capsules

DFD-29

Doxycycline DRUG

Doxycycline 40 mg capsules

Doxycycline 40 mg

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 18 years and above.
• Subjects must be in good general health as determined by the investigator and supported by the medical history.
• Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline.
• Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline.
• Subjects must have not more than 2 nodules or cysts at Baseline.

You may not qualify if:

• Female subjects who are pregnant or nursing or planning to become pregnant during the study.
• Male subjects whose female partner is planning to conceive a child.
• Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial.
• History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
• History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
• Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Sponsors & Collaborators

• Journey Medical Corporation: lead
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (24)

Clinical Trial Site 15

Santa Monica, California, 90404, United States

Location

Clinical Trial Site 01

Doral, Florida, 33178, United States

Location

Clinical Trial Site 02

Miami, Florida, 33173, United States

Location

Clinical Trial Site 14

Miami, Florida, 33175, United States

Location

Clinical Trial Site 05

Miramar, Florida, 33027, United States

Location

Clinical Trial Site 08

Clarksville, Indiana, 47129, United States

Location

Clinical Trial Site 16

Plainfield, Indiana, 46168, United States

Location

Clinical Trial Site 10

Louisville, Kentucky, 40241, United States

Location

Clinical Trial Site 11

Saint Joseph, Missouri, 64506, United States

Location

Clinical Trial Site 09

Cincinnati, Ohio, 45246, United States

Location

Clinical Trial Site 04

Dublin, Ohio, 43016, United States

Location

Clinical Trial Site 06

Anderson, South Carolina, 29621, United States

Location

Clinical Trial Site 12

Austin, Texas, 78759, United States

Location

Clinical Trial Site 03

Houston, Texas, 77056, United States

Location

Clinical Trial Site 07

Pflugerville, Texas, 78660, United States

Location

Clinical Trial Site 17

Bad Bentheim, 48455, Germany

Location

Clinical Trial Site 24

Berlin, 10247, Germany

Location

Clinical Trial Site 22

Bochum, 44793, Germany

Location

Clinical Trial Site 20

Darmstadt, 64283, Germany

Location

Clinical Trial Site 25

Dülmen, 48249, Germany

Location

Clinical Trial Site 19

Hamburg, 22391, Germany

Location

Clinical Trial Site 21

Langenau, 89129, Germany

Location

Clinical Trial Site 23

Merzig, 66663, Germany

Location

Clinical Trial Site 18

Wuppertal, 42287, Germany

Location

Related Publications (1)

• Bhatia N, Del Rosso J, Stein Gold L, Lain E, Draelos ZD, Sidgiddi S; MVOR-1 and MVOR-2 Study Investigators. Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2025 May 1;161(5):499-507. doi: 10.1001/jamadermatol.2024.6542.

  PMID: 40042869 DERIVED

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Srinivas Sidgiddi
• Organization: Journey Medical Corporation

ssidgiddi@jmcderm.com

9084585362

Study Officials

• Srinivas R Sidgiddi, M.D.

  Journey Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multinational, multicenter, randomized, parallel-group, double-blind, controlled study.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: March 29, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Locations

US (15); DE (9)